With the purpose of evaluating the clinical efficacy, side effects and usefulness of sisomicin (SISO) objectively, a double-blind study was performed in complicated urinary tract infections, using gentamicin (GM) as the control drug, and the results obtained are summarized as follows:
1. From a total 211 cases, 6 cases were excluded from all analysis, and 39 cases partially excluded while 166 cases were evaluated with regard to clinical efficacy and usefulness of SISO and GM. Side effects were assessed in 205 cases, including the partial exclusion.
2. In the background characteristics bf the evaluated cases (82 SISO-treated cases and 84 GMtreated cases), no significant differences were noted between both treatment groups.
3. In regard to the clinical efficacy, the cure rate (“excellent” and “good” cases according to the criteria determined by the subcommittee of the research group) in the SISO group and GM group was 46.3% and 59.5%, respectively, with no significant differences between both groups.
4. According to the evaluation on usefulness by the physicians in charge, both drugs were determined to be “very useful” or “useful” in more than 60% of cases. Noticeably, SISO was significantly useful in the cases with complicated pyelonephritis, and GM chronic complicated cystitis.
5. In regard to the bacteriological response, GM was significantly effective, as compared with SISO, by both the overall analysis on total cases and in some items by stratified analysis.
The result of the analysis on eradication/persistence of each clinical isolate, including those from mixed infections, was that the SISO group showed a slightly higher eradication rate in Pseudomonas aeruginosa and the GM group in Serratia. However, both drugs showed comparable results when all the Gram-negative bacilli were analyzed together.
6. In regard to the improvement rate of pyuria and pyrexia, there were no significant differences between both treatment groups. As to lumbago and vesical symptoms, SISO group had a significantly higher improvement rate than the GM group.
7. Side effects and abnormal laboratory findings occurred at a low frequency in both treatment groups, and there were no significant differences between both drugs.
8. It is suggested that.SISO has an equivalent efficacy to GM. in the treatment of complicated urinary tract infections.

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[in Japanese]

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Bleomycin has been shown to have a significant therapeutic effect against squamous cell carcinomas, particularly those of well differentiated type. Through a new therapeutic approach, combining an analog of the bleomycin (NK 631) and irradiation, a synergistic effect against squamous cell carcinomas of the oral cavity has been achived, yielding the following results:
1) Ten patients with squamous cell carcinomas of the oral cavity have been treated by the new therapeutic approach combining NK 631 and irradiation.
2) This therapeutic approach was markedly effective in treating well differentiated squamous cell carcinomas.
3) Poorly differentiated squamous cell carcinomas of the oral cavity were refractory to this treatment.
4) Pulmonary fibrosis has developed in none of our cases. The side effects, observed included stomatitis occurring in the majority of the cases, and generalized eruptions developing in one case.
5) The combination therapy was scheduled as described below:
i) In the 1st week, application of NK 631, 5 mg at a time, and serial exposure to irradiation with 200 rads at a time were done simultaneously on 5 consecutive days (i.e., 5 times in total from Monday through Friday).
ii) In the second week, application of NK 631 without irradiation was done every other day (3 times) on Monday, Wednesday and Friday.
iii) In the 3rd week, application of NK 631 was done on a dosage schedule of 5 mg, every other day (3 times) i.e., on Monday, Wednesday and Friday, and the irradiation, on a dosage schedule of 200 rads, on 5 consecutive days from Monday through Friday.
iv) After a 3-week interruption of the treatment from the 4th to the 6th week for relieving the patient of side effects, the patient was operated on, or placed back on the combination therapy, re-starting on the dosage schedule for the 3 rd week.

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[in Japanese]

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[in Japanese]

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[in Japanese]

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[in Japanese]

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Clinical study on bacampicillin (BAPC) granules was performed in 20 children with infectious diseases.
Patients treated with BAPC granules were 10 cases of scarlet fever, 3 cases of pertussis, 3 cases of Salmonella enteritis and 4 cases of acute enteritis.
Clinical results were excellent in 2, good in 9, fair in 3, poor in 4 and unknown in 2.
No side effect was observed.

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We investigated bacampicillin (BAPC) granules in the field of pediatrics.
1) Average serum levels after administration of BAPC granules at a dose of 10mg/kg as ABPC were 6.8μg/ml at 1 hour, 1.4μg/ml at 6 hours. Average urinary excretion rate till 6 hours was 84.5%. Those results were almost same as those obtained with BAPC tablet.
2) We treated patients with acute tonsillitis, lacunar tonsillitis and acute bronchitis by BAPC granules at a dose of 30-40 mg potency/kg for 3-5 days, and excellent results were obtained.
3) In the case of streptococcal infections including scarlet fever, pharyngeal streptococci disappeared 1-2 days after administration and did not reappeared.
4) BAPC granules were easy to intake for children and no abnormal laboratory finding was observed.
5) BAPC granules seem to be useful for treatment of pediatric infections.

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The teratogenicity study of fosfomycin-Ca (FOM-Ca) was undertaken in Wistar strain rats and JW strain rabbits.
Rats were treated orally at dose levels of 140,700 and 1,400 mg/kg/day from 7th to 17th day of gestation, and rabbits were treated orally at dose levels of 80,140 and 420 mg/kg/day from 6th to 18th day of gestation.
In the case of rats, two-thirds of pregnant mothers in each group were sacrificed on 20th day of gestation and then their fetuses were examined for external, visceral and skeletal observation. The remaining mothers were allowed to deliver naturally, and then their offsprings were examined for postnatal development.
In the case of rabbits, all pregnant mothers were sacrificed on 29th day of gestation and their fetuses were examined.
No effect of FOM-Ca treatment to rat and rabbit mothers was found except soft stool was seen with maximum dose in rats.
Dead or resorbed rate of fetuses increased, external anomalies (short tail, abdominal hernia) were found and skeletal anomalies slight increased with maximum dose in rats.
However, there was no significant difference from the control or background data.
While, no effect of FOM-Ca treatment was observed in rabbits and rat offsprings.
Consequently, it can be concluded that FOM-Ca has no teratogenicity effects on rats and rabbits

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The clinical efficacy of a macrolide antibiotic, midecamycin, was studied in 12 adult cases with Mycoplasma pneumoniae pneumonia.
The therapeutic effects were excellent or good in 9 cases and fair in 2 cases.
On defervescence and disappearance of shadows on chest X-ray the therapeutic effect was satisfactory, but on disappearance of cough therapeutic effect was not clear in some cases. Taking into consideration the antimicrobial activity of midecamycin against Mycoplasma pneumoniae, serum concentration and side effects of midecamycin, this antibiotic is expected to be effective in the treatment of Mycoplasma pneumoniae pneumonia.

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